[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510105":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":26,"responsibleParty":40,"collaborators":26,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":26,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":26,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":26},{"fullName":5,"class":6},"Rambam Health Care Campus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"cervical ripening balloon for 1 hour","EXPERIMENTAL","Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician",[13],"Device: cervical ripening balloon for one hour",{"label":15,"type":16,"description":17,"interventionNames":18},"cervical ripening balloon for 12 hours","ACTIVE_COMPARATOR","Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after 12 hours in the control group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician",[19],"Device: cervical ripening balloon for twelve hours",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","cervical ripening balloon for one hour","The cervical ripening balloon will be left in place for one hour and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"cervical ripening balloon for twelve hours","The cervical ripening balloon will be left in place for for twelve hours and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room",[15],[32],{"name":33,"affiliation":5,"role":34},"Naphtali Justman","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","0546836644","njustman88@gmail.com",{"type":41,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100510105","cervical-ripening-balloon-for-12-hours-vs-1-hour-100510105",false,"NCT05922111","Cervical Ripening Balloon for 12 Hours vs. 1 Hour.","Comparison of Labor Induction With Cervical Ripening Balloon, One Versus Tweleve Hours Placement: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Nulliparous or multiparous gravidas\n2. Gestational age ≥ 370\u002F7 to 416\u002F7 gestational weeks\n3. Age 18-45\n4. Signed informed consent\n\nExclusion Criteria:\n\n1. Contraindications for vaginal delivery\n2. Multifetal gestation\n3. Rupture of membranes\n4. Bishop score \\> 6\n5. The cervix is dilated to more than 2 cm\n6. Previous caesarean delivery",true,"FEMALE","18 Years","45 Years",{"count":54,"type":55},164,"ESTIMATED","INTERVENTIONAL",[58],"NA","The aim of this study is a comparison of induction of labor with a cervical ripening balloon left in place for one hour compared to twelve hours. The primary outcome is time to delivery.\n\nWomen admitted for induction of labor will be recruited and randomized to either a cervical ripening balloon for one hour or twelve hours. the management of delivery after the extraction of the balloon will be left to the discretion of the attending physician.",[61],"Induction of Labor","NOT_YET_RECRUITING","2023-06-18",{"date":65,"type":66},"2023-06-28","ACTUAL",{"date":68,"type":55},"2023-08-01",{"date":70,"type":55},"2026-06-30",{"name":5,"class":6}]